Federal Health Policy Update for Friday, July 16

The following is the latest health policy news from the federal government as of 2:45 p.m. on Friday, July 16.  Some of the language used below is taken directly from government documents.

White House

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS is providing notifications to facilities that were determined to be out of compliance with Quality Reporting Program (QRP) requirements for CY 2020, which will affect their FY 2022 Annual Payment Update (APU).  Non-compliance notifications are being distributed by the Medicare Administrative Contractors (MACs) and were placed into facilities’ CASPER folders in QIES, for Hospice and SNFs, and into facilities’ My Reports folders in iQIES for IRFs and LTCHs onJuly 14, 2021.  Facilities that receive a letter of non-compliance may submit a request for reconsideration to CMS via email no later than11:59 pm on August 13, 2021. Facilities that receive a notice of non-compliance and would like to request a reconsideration should see the instructions in their notice of non-compliance and on the appropriate QRP webpage:
  • The Medicare Geographic Classification Review Board application is available for the FY 2023-2025 reclassification cycle.  The current application and reinstatement period is open through September 1, 2021.  MGCRB rules have been updated, effective immediately, to update several administrative items, specifically:
    • MGCRB mailing address (for use with statewide applications)
    • S. Census Bureau links in Appendix C (for most recent reference maps (March 2020))
    • clarification of Rule 3.1 to address acceptance of correspondence subsequent to submitting the initial application

Go here for MGCRB rules, frequently asked questions, and electronic filing support.

Provider Relief Fund

  • The “reporting requirements and auditing” section of the Provider Relief Fund web page has been updated.  The Provider Relief Fund FAQ page also has been updated with new questions on pages 2, 14, 23, and 31.  Fund recipients should review these changes carefully.
    • One particular new question is noteworthy:  on page 31, the question asks “How do I appeal or dispute a decision made?”  The response is:  “HHS recognizes that providers may have questions regarding the accuracy of their PRF payments. HHS is developing a structured reconsiderations process to review and reconsider payment accuracy based on submitted supporting documentation.  Details regarding this process will be provided in coming weeks.”

Department of Health and Human Services

COVID-19

  • HHS has announced the availability of an estimated $103 million in American Rescue Plan funding over a three-year period to reduce burnout and promote mental health among the health workforce.  Awards will take into particular consideration the needs of rural and medically underserved communities, will seek to help health care organizations establish a culture of wellness  among the health and public safety workforce, and will seek support training that builds resiliency for those at the beginning of their health careers.  There are three funding opportunities for which HHS will accept applications:
  • Promoting Resilience and Mental Health Among Health Professional Workforce – approximately 10 awards will be made totaling approximately $29 million over three years to health care organizations to support members of their workforce.  This includes establishing, enhancing, or expanding evidence-informed programs or protocols to adopt, promote, and implement an organizational culture of wellness that includes resilience and mental health among their employees.
  • Health and Public Safety Workforce Resiliency Training Program – approximately 30 awards will be made totaling approximately $68 million over three years for educational institutions and other appropriate state, local, Tribal, public, or private non-profit entities training those early in their health careers.  This includes providing evidence-informed planning, development, and training in health profession activities to reduce burnout and suicide and promote resiliency among the workforce.
  • Health and Public Safety Workforce Resiliency Technical Assistance Center – one award will be made for approximately $6 million over three years to provide tailored training and technical assistance to HRSA’s workforce resiliency programs.

See the HHS announcement here.  To apply for the Provider Resiliency Workforce Training Notice of Funding Opportunities, visit Grants.gov.  Applications are due August 30, 2021.

  • HHS has awarded nearly $144 million in American Rescue Plan funding to 102 HRSA Health Center Program look-alikes (LALs) to respond to and mitigate the spread of COVID-19 and enhance health care services and infrastructure in communities across the country.  LALs are community-based health care providers that provide essential primary health care services to underserved communities and vulnerable populations but do not otherwise receive HRSA Health Center Program funding.  Learn more in the HHS announcement about the funding, which also has a link to a list of grant recipients.

National Institutes of Health

  • High-dose buprenorphine therapy, provided under emergency department care, is safe and well tolerated in people with opioid use disorder experiencing opioid withdrawal symptoms, according to a study supported by the National Institutes of Health’s National Institute on Drug Abuse through the Helping to End Addiction Long-term Initiative, or the NIH HEAL Initiative.  Go here to learn more.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has published its annual data book, which provides information on national health care and Medicare spending as well as Medicare beneficiary demographics, dual-eligible beneficiaries, quality of care in the Medicare program, and Medicare beneficiary and other payer liability.  It also examines provider settings and presents data on Medicare spending, beneficiaries’ access to care in the setting, and the sector’s Medicare profit margins, if applicable.  Find the data book here.

Congressional Research Service

  • In June the Occupational Safety and Health Administration (OSHA) promulgated an emergency temporary standard (ETS) for the prevention of the transmission of COVID-19 in health care employment settings.  OSHA has not used this authority since 1983, and the Congressional Research Service has prepared a report on what the ETS means and how it works.  Find that report here.

Stakeholder Events

Monday, July 19 – National Emergency Management Association (NEMA)

Mission-Ready Packages Workshop for Resource Providers

Monday, July 19 at 1:00 pm ET  Click here for registration

NEMA is hosting a workshop on developing mission ready packages (MRPs). MRPs are specific response or recovery capabilities that have been created to ensure the skills, capabilities, and associated costs are bundled prior to an emergency or disaster for more efficient deployment. These workshop sessions are designed for resource providers. A resource provider is any organization that is able to deploy under the Emergency Management Assistance Compact (EMAC) and that has capabilities that might be needed during an emergency response. Previous knowledge of EMAC or MRPs is not required.

Tuesday, July 20 – Health Resources and Services Administration (HRSA)

Provider Relief Fund Reporting Requirements

Tuesday, July 20 at 3:00 pm ET

HRSA will host a recorded Reporting Technical Assistance session to provide technical assistance on reporting requirements for Provider Relief Fund recipients and stakeholders.  To register for the July 20 session go here.

Wednesday, August 4 – Centers for Disease Control

Zoonoses and One Health Update (ZOHU) Call

Wednesday, August 4 at 2:00 – 3:00 pm ETClick here for more information

ZOHU Calls are one-hour monthly webinars that provide timely education on zoonotic and infectious diseases, One Health, antimicrobial resistance, food safety, vector-borne diseases, recent outbreaks, and related health threats at the animal-human-environment interface.

 

Federal Health Policy Update for Monday, June 28

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, June 28.  Some of the language used below is taken directly from government documents.

Supreme Court Decision in Affordable Care Act Case

  • The Supreme Court has declined to hear an appeal of a case in which insurers unsuccessfully sued to recover reductions in their Affordable Care Act federal cost-sharing reduction payments.

White House

Department of Health and Human Services

COVID-19

  • HHS and the FDA have paused all distribution of bamlanivimab and etesevimab together and etesevimab alone, to pair with existing supply of bamlanivimab, on a national basis until further notice.  In addition, the FDA has recommended that health care providers nation-wide use alternative authorized monoclonal antibody therapies and not use bamlanivimab and etesevimab administered together at this time.  Learn more about why the agencies have taken this action and what they propose as alternatives from this message distributed by HHS’s Office of the Assistant Secretary for Preparedness and Response,
  • HHS’s Office of the Inspector General has published a report on the impact of COVID-19 on Medicare beneficiaries residing in nursing homes during 2020.  Learn more from the OIG’s announcement and summary of the report and from the OIG report “COVID-19 Had a Devastating Impact on Medicare Beneficiaries in Nursing Homes During 2020.”

Health Policy News

  • HHS and the CDC have awarded 59 jurisdictions with $200 million to bolster support for and enhance the disease intervention specialists workforce.  These awards represent the initial funding of a $1.13 billion investment being made over the next five years under the American Rescue Plan and will provide these jurisdictions, public health programs, and the CDC with support to expand and leverage the work of disease intervention specialists.  Learn more from the CDC’s announcement and find a list of the funding recipients here.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has provided guidance to state Medicaid programs about the circumstances under which health care facilities still operating under their emergency preparedness plans because of COVID-19 will temporarily remain exempt from participating in required full-scale emergency preparedness exercises and testing.  See the CMS guidance letter here.

Health Policy News

  • CMS has announced the appointment of Daniel Tsai as deputy administrator and director of its Center for Medicaid and CHIP Services.  Tsai comes from Massachusetts, where he served as the assistant secretary for MassHealth and state Medicaid director.  Learn more about Tsai and the agency he will help lead in this CMS news release.
  • CMS has released a Center for Medicaid and CHIP Services bulletin to introduce a series of tools and toolkits for states and CMS to use to improve the monitoring and oversight of managed care in Medicaid and the Children’s Health Insurance Program (CHIP) that will help improve beneficiaries’ access to care.  This bulletin also provides guidance setting the content and format of the Annual Managed Care Program Report required by CMS regulations and introduces additional resources and technical assistance toolkits that states can use to improve compliance with managed care standards and requirements.  Learn more from the new CMS bulletin.
  • CMS has published the latest edition of MLN Connects, its online publication.  For articles about updates of the hospital outpatient prospective payment system and the clinical laboratory fee schedule and more, go here.
  • CMS has updated its FAQ on its final rule on interoperability and patient access.  Find the information here.
  • CMS announced that it will provide $20 million in American Rescue Plan money to support state-based marketplaces to improve access to affordable, comprehensive health insurance coverage for consumers in their states.  States can apply for funding to help modernize or update their systems, programs, or technology to comply with federal marketplace requirements.  Learn more about the new funding from this CMS announcement.
  • CMS’s Center for Medicare and Medicaid Innovation has announced an anti-kickback safe harbor for CMS-sponsored model patient incentives under the agency’s Maternal Opioid Misuse Model.  Learn more here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Health Policy News

  • The FDA has approved the drug Pradaxa (dabigatran etexilate), the first oral blood thinning medication for children.  Learn more from this FDA news release.
  • The FDA has issued draft guidance encouraging industry to include patients with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in cancer clinical trials regardless of whether they have received existing alternative treatment options.  See the FDA announcement of this new policy and the draft guidance itself, which was published in the Federal Register.

Occupational Safety and Health Administration

  • OSHA has issued an emergency temporary standard to protect health care and health care support service workers from occupational exposure to COVID-19 in settings where people with COVID-19 are reasonably expected to be present.  Compliance with some of the new requirements is mandatory as of July 6 and compliance with the rest of the requirements is mandatory as of July 21.  Learn more from OSHA’s notice in the Federal Register.

National Institutes of Health

  • NIH director Francis S. Collins and other leaders have outlined their vision for a new science entity, the Advanced Research Projects Agency for Health, that was included in the president’s fiscal year 2022 budget with requested funding of $6.5 billion.  The purpose of the agency is to accelerate biomedical innovation and adoption of technologies and approaches to revolutionize health care and medicine.  Find the NIH announcement and a link to additional information about the agency here.
  • An NIH study published in the journal Science Translational Medicine concludes that “…there were 4.8 undiagnosed SARS-CoV-2 infections for every diagnosed case of COVID-19, and an estimated 16.8 million infections were undiagnosed by mid-July 2020 in the United States.”  Find the study here.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has submitted formal comments to CMS about that agency’s proposed regulation describing how it plans to pay for acute-care hospital and long-term-care hospital inpatient care in FY 2022.  The MedPAC letter addresses limited parts of the proposed regulation.  Go here to see MedPAC’s letter to CMS.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has published a fact sheet with an updated analysis of physician acceptance of new Medicaid patients, including at the state level.  The analysis found that physicians were significantly less likely to accept new patients covered by Medicaid than patients with Medicare or private insurance, although acceptance varied by specialty and by state.  Learn more from the new MACPAC fact sheet “Physician Acceptance of New Medicaid Patients:  Findings from the National Electronic Health Records Survey.”
  • MACPAC has published an issue brief that describes how Medicaid programs can pay for certain housing-related services.  Learn more from the MACPAC issue brief “Medicaid’s Role in Housing.”

Government Accountability Office

Stakeholder Events

CMS – Coronavirus (COVID-19) Stakeholder Calls 

HHS’s “We Can Do This” campaign is a national initiative to build confidence in COVID-19 vaccines and get more people vaccinated.  This campaign offers tailored resources and toolkits for stakeholders to use to provide COVID-19 vaccine information to at-risk populations.  CMS is partnering with the campaign to offer several webinars to walk through each toolkit and its resources and train community organizations, local voices, and trusted leaders to use the campaign tools for vaccine outreach efforts to diverse communities.  Webinar dates and registration links are below:

  • Tuesday, June 29, 1:00-1:30 pm ET:  Faith-Based Toolkit – Register here
  • Thursday,  July 1, 1:00-2:00 pm ET:  Toolkits for Racial and Ethnic Minority Communities – Register here
  • Thursday, July 8, 1:00-1:30 pm ET:  Older Adults Toolkit – Register here

Wednesday, Thursday, and Friday, July 7, July 8, and July 9 CMS

CMS – Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set

CMS will hold virtual meetings on July 7, 8, and 9, to discuss its preliminary coding recommendations for revisions of the HCPCS Level II code set.  For information about times, registration, submission of materials, signing up to speak, and submitting comments, click here.

Tuesday, July 13 Office of the National Coordinator for Health Information Technology (ONC)
ONC Workshop: Advancing SDOH Data Use and Interoperability for Achieving Health Equity
Tuesday, July 13 at 10:00 am – 4:00 pm ET  Click here for connection information
This workshop will explore existing and emerging data standards, tools, approaches, policies, models, and interventions for advancing the use and interoperability of non-clinical health data for individual and community health improvement.  It will share varying perspectives of health policy-makers and health improvement implementers to highlight inventive solutions, share challenges, and offer ideas on data modernization to advance health equity.  The workshop offers introductory content as well as deep exploration of key topics as part of social determinants of health IT data use and interoperability including facilitated, expert stakeholder engagement.

Federal Health Policy Update for Tuesday, June 15

The following is the latest health policy news from the federal government as of 3:30 p.m. on Tuesday, June 15.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • Reduced hospital admissions as a result of people deferring needed medical care during the pandemic could jeopardize safety-net hospitals’ continued eligibility for the section 340B prescription drug program.  Two bills currently in Congress, H.R. 3203 and S. 773, would protect safety-net hospitals and others from this one-year anomaly and NASH has written to members of Congress asking them to co-sponsor and support those bills.  See NASH’s letter to members of Congress.

Provider Relief Fund

  • Late last week HHS announced that it has increased the amount of time providers will have to report information and extended key deadlines for expending Provider Relief Fund payments for recipients that received payments after June 30, 2020.  The revised reporting requirements will be applicable to providers that received one or more payments exceeding, in the aggregate, $10,000 during a single payment-received period from the Provider Relief Fund General Distributions, Targeted Distributions, and/or Skilled Nursing Facility and Nursing Home Infection Control Distributions.  For additional information, see the following resources:

HHS also has updated its Provider Relief Fund FAQ to reflect those changes.  The changes in the FAQ, which address how much time fund recipients have to spend their grants, how they must report on their spending, how audits will be conducted, and how certain data elements in the reporting requirements are defined, can be found within the document on pages 8, 14, 16, 22-25, and 40.  HHS also has updated the FAQ section of the Provider Relief Fund web site and the reporting requirements and auditing section of that site to reflect these changes.

Department of Health and Human Services

COVID-19

  • HHS announced that it has provided $424.7 million in funding from the American Rescue Plan to more than 4200 Rural Health Clinics (RHCs) for COVID-19 testing and mitigation.  Later this summer HHS will issue up to $35.3 million in additional funding to RHCs that meet eligibility requirements.  Funding is based on how many certified clinic sites RHCs operate and is $100,000 for each clinic site.  RHCs will use the money to maintain and increase COVID-19 testing, expand access to testing for rural residents, and broaden efforts to mitigate the spread of the virus in ways tailored to local communities.  See HHS’s announcement about the funding.
  • HHS’s Office of the Secretary for Preparedness and Response has published a document titled “Innovations in COVID-19 Patient Surge Management” that offers brief case studies on how four different jurisdictions handled major increases in COVID-19 cases.

Health Policy News

  • HHS’s Office of the Secretary for Preparedness and Response has published a new table-top exercise toolkit to help emergency planners create an interactive, discussion-based exercise focusing on the effects on health care coalitions and health care facilities of large numbers of patients seeking care following exposure to an infectious agent.  Find the toolkit here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

  • The FDA announced that it has authorized the use of a limited supply of Johnson & Johnson COVID-19 vaccine manufactured at a plant that is not yet an authorized manufacturing facility.  At the same time, it concluded that some vaccine materials manufactured in that same plant may not be used for COVID-19 vaccines.  In addition, the FDA has extended the expiration date for the refrigerated Johnson & Johnson vaccine after reviewing information submitted by the company.  Learn more from this FDA news release.
  • In a new episode of the FDA Office of Minority Health and Health Equity Forum Podcast, Rear Admiral Richardae Araojo discusses FDA’s emergency use authorization process with Rear Admiral Denise Hinton, the FDA’s chief scientist.  Go here for a transcript of the discussion and to find a link to the podcast itself.

National Institutes of Health

  • The NIH reports that results from a Phase 3 clinical trial show that the Novavax investigational vaccine demonstrated 90.4 percent efficacy in preventing symptomatic COVID-19 disease.  The vaccine showed 100 percent protection against moderate and severe disease.  In people at high risk of developing complications from COVID-19 the vaccine showed 91 percent efficacy in preventing symptomatic COVID-19 disease.  Learn more from the NIH news release.
  • The NIH announced that a new antibody testing study examining samples originally collected through its “All of Us” research program found evidence of COVID-19 infections in five states earlier than had initially been reported.  The results expand on findings from a CDC study that suggested that SARS-CoV-2, the virus that causes COVID-19, was present in the U.S. as far back as December of 2019.  See the NIH news release here.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has released its annual report to Congress.  The report includes:
  • Mandatory reports that evaluate the skilled nursing facility value-based purchasing program; assess the impact of recent changes in Medicare’s clinical laboratory fee schedule payment rates; and examine the relationship between clinician services and other Medicare services.
  • Reports requested by Congress on private equity and Medicare and Medicare beneficiaries’ access to care in rural areas (an interim report).
  • Additional reports on rebalancing Medicare Advantage benchmark policy; streamlining CMS’s portfolio of alternative payment models; revising Medicare’s indirect medical education payments to better reflect teaching hospitals’ costs; Medicare vaccine coverage and payment; and improving Medicare’s policies for separately payable drugs in the hospital outpatient prospective payment system.

Learn more from MedPAC’s announcement about its June report and find the report itself here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has sent its annual report to Congress.  The report addresses high-cost specialty drugs in the Medicaid program; access to mental health services for those enrolled in Medicaid and the State Children’s Health Insurance Program (CHIP); integration of physical and behavioral health care through electronic health records; Medicaid’s non-emergency transportation benefit; and state strategies for integrating care for people who are dually eligible for Medicaid and Medicare.  See MACPAC’s announcement about its report here and find the report itself here.

National Association of Medicaid Directors

  • The National Association of Medicaid Directors has published “Medicaid Forward,” which it describes as identifying “…opportunities for action to address immediate and long-term challenges for children’s health emerging from the COVID crisis across communities.  The report is amplified by real-world examples of states that have implemented the strategies outlined in the framework.”

Government Accountability Office

  • The Medicare Access and CHIP Reauthorization Act of 2015 established the Physician-Focused Payment Model Technical Advisory Committee to provide comments and recommendations to HHSSHH on physician payment models and gave the Comptroller General responsibility for appointing its members.  GAO is now accepting nominations of individuals to serve on this committee.  Letters of nomination and resumes should be submitted no later than July 16.  Learn more from this notice published in the Federal Register.

Stakeholder Events

Wednesday, June 16 – FDA

Virtual Town Hall Series – Coronavirus (COVID-19) Test Development and Validation
Wednesday, June 16 at 12:15 pm ET  Click here for connection information
The FDA will host a virtual town hall for COVID-19 test developers.  The purpose of this town hall is to help answer technical questions about the development and validation of tests for COVID-19.

Wednesday and Thursday, June 16 and June 17 – FEMA

COVID-19 Pandemic Operational Guidance Webinars
Wednesday, June 16 at 7:00 at 8:00 pm ET  Click here for connection information

FEMA is offering a series of webinars throughout the month of June to further educate people on its pandemic operational guidance.  The webinar will cover information included in COVID-19 Pandemic Operational Guidance: All Hazards Incident Response and Recovery, a document aimed at helping emergency managers plan for disaster response and recovery while adhering to public health guidelines to prevent the spread of COVID-19.  This is webinar is also being offered on Thursday, June 17 at 1:00 – 2:00 PM.

Thursday, June 17 – U.S. Health Sector Cybersecurity Coordination Center (HC3)
HC3 Cybersecurity Threat Briefing on Threat Hunting
Thursday, June 17 at 1:00 pm ET  Click here to learn more
HHS’s HC3 program invites stakeholders to join its second cybersecurity threat briefings in June; the topic will be “Threat Hunting.”  This initiative will provide actionable information on health sector cybersecurity threats and mitigations.  HC3 analysts will present relevant cybersecurity topics, engage in discussions with participants on current threats, and highlight best practices and mitigation tactics.

Thursday, June 17 – CDC
Evaluating and Caring for Patients with Post-COVID Conditions
Thursday, June 17 at 2:00 – 3:00 pm ET  Click here to learn more

During this CDC Clinician Outreach and Communication Activity (COCA) Call, clinicians will learn about the CDC’s new interim guidance that provides a framework for health care providers in their initial assessment, evaluation, management, and follow-up of persons with possible post-COVID conditions. Post-COVID conditions refer to the wide range of physical and mental health consequences experienced by some patients that are present four or more weeks after COVID-19 infection, including by patients who had initial mild or asymptomatic acute infection.

Friday, June 18 – Office of the National Coordinator for Health Information Technology (ONC)
ONC Workshop: Advancing Social Determinants of Health Data Use and Interoperability for Achieving Health Equity
Friday, June 18 at 10:00 am – 4:30 pm ET  Click here to learn more
This workshop will explore existing and emerging data standards, tools, approaches, policies, models, and interventions for advancing the use and interoperability of non-clinical health data for individual and community health improvement.  It will enable varying perspectives of health policy-makers and health improvement implementers to highlight inventive solutions, share challenges, and review ideas on data modernization to advance health equity.  The workshop offers introductory content as well as deep exploration of key topics as part of social determinants of health IT data use and interoperability, including facilitated, expert stakeholder engagement.

Tuesday, June 22 – FDA
FDA Drug Topics: Overview of Risk Evaluation and Mitigation Strategies (REMS) for Health Care Providers
Tuesday, June 22 at 1:00 – 2:15 pm ET  Click here to learn more
This webinar will provide an overview of REMS and discuss how REMS safety requirements affect prescribers, dispensers, and patients.  Participants should gain an understanding of the REMS authorities, how REMS are implemented, and the entities that provide oversite and support.  REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure that the benefits of the medication outweigh its risks.

Wednesday, Thursday, and Friday, July 7, July 8, and July 9 – CMS

CMS – Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set

CMS will hold virtual meetings on July 7, 8, and 9, to discuss its preliminary coding recommendations for revisions of the HCPCS Level II code set.  For information about times, registration, submission of materials, signing up to speak, and submitting comments, click here.

CMS – Coronavirus (COVID-19) Stakeholder Calls 

HHS’s “We Can Do This” campaign is a national initiative to build confidence in COVID-19 vaccines and get more people vaccinated.  This campaign offers tailored resources and toolkits for stakeholders to use to provide COVID-19 vaccine information to at-risk populations.  CMS is partnering with the campaign to offer several webinars to walk through each toolkit and its resources and train community organizations, local voices, and trusted leaders to use the campaign tools for vaccine outreach efforts to diverse communities.

Webinar dates and registration links are below:

  • Thursday, June 17 1:00-1:30 pm ET: Rural Toolkit – Register here
  • Tuesday, June 22, 1:00-1:30 pm ET: Spanish Language Toolkits – Registration TBD*
  • Thursday June 24, 1:00-1:30 pm ET: Healthcare workers Toolkit – Registration TBD
  • Tuesday, June 29, 1:00-1:30 pm ET: Faith-Based Toolkits – Registration TBD
  • Thursday, July 1, 1:00-2:00 pm ET: Toolkits for Racial and Ethnic Minority Communities – Registration TBD
  • Thursday, July 8, 1:00-1:30 pm ET: Older Adults Toolkit – Registration TBD

Go here for registration information for the remaining dates.

Health Policy Update for Tuesday, June 8

The following is the latest health policy news from the federal government as of 2:45 p.m. on Tuesday, June 8.  Some of the language used below is taken directly from government documents.

White House

Health Policy News

COVID-19

  • The White House has posted transcripts of the June 3 and June 8 press briefings given by its COVID-19 response team and public health officials.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • According to reports, Jon Blum will join CMS as principal deputy administrator, the same position he held during the Obama administration.  Also, Erin Richardson, currently a lobbyist for the Federation of American Hospitals, will join CMS as administrator Chiquita Brooks-LaSure’s chief of staff.  Ms. Richardson served on the White House Domestic Policy Council during the Obama administration.
  • CMS has published a guide to using the health-related social needs screening tool from the Accountable Health Communities Model.  Health-related social needs are individual-level, adverse social conditions that negatively affect individuals’ health care and are distinguished from social determinants of health.  Find the guide here.
  • CMS has issued a 2021 navigator notice of funding opportunity that will make $80 million in grant funding available to navigators in states with a federally-facilitated marketplace for the 2022 plan year.  Go here to see CMS’s announcement about the funding and go here to see formal notice of the funding opportunity.  Applications are due July 6.

Department of Health and Human Services

Health Policy News

  • HHS’s Office of the Assistant Secretary for Preparedness and Response has issued a warning describing current vulnerabilities, including to ransomware threats, for selected health care information systems.  Find that notice here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Health Policy News

  • The FDA has approved Aduhelm (aducanumab) for the treatment of Alzheimer’s.  Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.  Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit.  Go here to see the FDA announcement and go here for further information about Aduhelm.

Medicare Payment Advisory Commission

Patient-Centered Outcomes Research Institute

  • PCORI, a non-profit organization created through the Affordable Care Act, is launching a Health Systems Implementation Initiative that it says it hopes will “…provide a channel to facilitate real-world uptake and use of evidence in healthcare delivery systems.”  To this end, PCORI has published a request for information through which it seeks “…to learn about health systems’ interest in undertaking implementation projects to improve care delivery based on findings from PCORI-funded research and related evidence.  Further, PCORI seeks feedback regarding the incentives and support that would enable health systems to undertake these activities.”  See an introduction to the project here and find the RFI here.  Questions are due by June 24 and responses are due by July 15.

Stakeholder Events

Wednesday, June 9 – FDA

Virtual Town Hall Series- Coronavirus (COVID-19) Test Development and Validation
Wednesday, June 9 at 12:15 pm ET  Click here for connection information
FDA will host a virtual town hall for COVID-19 test developers. The purpose of this town hall is to help answer technical questions about the development and validation of tests for COVID-19.

Thursday, June 10 – FEMA
COVID-19 Pandemic Operational Guidance Webinars
Thursday, June 10 at 11:00 am at 12:00 pm  ET Click here for connection information
FEMA is offering a series of webinars throughout the month of June to further educate people on the pandemic operational guidance.  The webinar will cover information included in the COVID-19 Pandemic Operational Guidance: All Hazards Incident Response and Recovery, a document aimed at helping emergency managers plan for disaster response and recovery while adhering to public health guidelines to prevent the spread of COVID-19.

Thursday, June 10 – CMS

Rural Health Open Door Forum

Thursday, June 10 at 2:00 ET

Items on the agenda include the FY 2022 inpatient prospective payment system rule, including graduate medical education policies, and a COVID-19 vaccination payment update.

This call will be by conference call only.  To participate by phone dial 1-888-455-1397 and reference conference passcode 8604468.  Persons participating by phone are not required to RSVP.  TTY Communications Relay Services are available for the hearing impaired.  For TTY services dial 7-1-1 or 1-800-855-2880 and a relay communications assistant will help.  Instant Replay is available by dialing 1-866-346-7095; no passcode needed.

Friday, June 11 – FDA
Identification of Medicinal Products: Path to Global Implementation
Monday, June 11 at 1:00 – 2:30 pm ET  Click here to learn more
FDA will present updates on the Identification of Medicinal Products standards development and implementation with an emphasis on international collaboration, pilot projects on substance, dosage form and pharmaceutical identification.

Friday, June 11 – FDA
Identification of Medicinal Products:  Path to Global Implementation
Monday, June 11 at 1:00 – 2:30 pm ET   Click here to learn more
The FDA will present updates on the identification of medicinal products standards development and implementation with an emphasis on international collaboration, pilot projects on substance, dosage form, and pharmaceutical identification.

Friday, June 18 – Office of the National Coordinator for Health Information Technology (ONC)
ONC Workshop: Advancing Social Determinants of Health Data Use and Interoperability for Achieving Health Equity
Friday, June 18 at 10:00 am – 4:30 pm ET  Click here to learn more
This workshop will explore existing and emerging data standards, tools, approaches, policies, models, and interventions for advancing the use and interoperability of non-clinical health data for individual and community health improvement.  It will enable varying perspectives of health policy-makers and health improvement implementers to highlight inventive solutions, share challenges, and review ideas on data modernization to advance health equity.  The workshop offers introductory content as well as deep exploration of key topics as part of social determinants of health IT data use and interoperability including facilitated, expert stakeholder engagement.

Tuesday, June 22 – FDA
FDA Drug Topics: Overview of Risk Evaluation and Mitigation Strategies (REMS) for Health Care Providers
Tuesday, June 22 at 1:00 – 2:15 pm ET  Click here to learn more
This webinar will provide an overview of REMS and discuss how the REMS safety requirements affect prescribers, dispensers and patients.  Participants should gain an understanding of the REMS authorities, how REMS are implemented, and the entities that provide oversite and support.  REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

Federal Health Policy Update for Thursday, June 3

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, June 3.  Some of the language used below is taken directly from government documents.

White House

Health Policy News

  • Late last week the Biden administration released its proposed FY 2022 budget.  Most of the health care provisions had already been disclosed and discussed prior to the formal budget release.  For additional information about the proposed budget, see the following resources:

COVID-19

  • President Biden announced a “National Month of Action” to mobilize a drive to get 70 percent of U.S. adults at least one COVID-19 shot by July 4.  Throughout the month, national organizations, local government leaders, community-based and faith-based partners, businesses, employers, social media influencers, celebrities, athletes, colleges, young people, and thousands of volunteers across the nation will be asked to work together to get their communities vaccinated.  Learn more about the various facets of this campaign in this administration fact sheet.

Congress

  • Representative Frank Pallone, chair of the House Energy and Commerce Committee, and Senator Patty Murray, chair of the Senate Health, Education, Labor and Pensions Committee, have released a letter “…requesting information on design considerations for legislation to develop a public health insurance option” with a stated goal of “…establishing a federally administered public option… to work towards achieving universal coverage, while making health care simpler and more affordable for patients and families.”  The letter invites interested parties to respond to eight specific questions about such a public health insurance option, with written comments due by July 31.  Find the Pallone/Murray letter here.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • CMS has posted the latest edition of its online publication MLN Connects.  Among items of interest in this edition are:
    • Medicare Shared Savings Program:  Submit Notice of Intent to Apply by June 7
    • Clinical Diagnostic Laboratories:  Key Dates for New & Reconsidered Test Codes
    • Clinical Diagnostic Laboratories:  Private Payor Rate-Based CLFS Resources
    • MACs Resume Medical Review on a Post-payment Basis
    • Improper Payment for Intensity-Modulated Radiation Therapy Planning Services
    • International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) – October 2021
    • National Coverage Determination (NCD) 110.24:  Chimeric Antigen Receptor (CAR) T-cell Therapy
    • National Coverage Determination (NCD) 210.3:  Screening for Colorectal Cancer (CRC) – Blood-Based Biomarker Tests
    • National Coverage Determination (NCD) Removal
    • Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Charge Payment

Go here for links to these and other items.

Department of Health and Human Services

COVID-19

  • HHS and its Health Resources and Services Administration (HRSA) have announced that $100 million in new funding is available through HRSA’s Rural Health Clinic Vaccine Confidence Program to support efforts to encourage residents of rural areas to receive COVID-19 vaccines.  Medicare-certified rural health clinics and organizations that own and operate such clinics are eligible for funding.  Learn more about the grant opportunity here.  Grant applications are due June 23.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

  • The FDA has recommended that health care workers and facilities transition away from crisis capacity personal protective equipment conservation strategies, such as using non-NIOSH-approved disposable respirators, including non-NIOSH-approved imported respirators such as KN95s.  This recommendation is in follow-up to an April 9, 2021 letter in which the FDA recommended a transition away from decontamination or bioburden-reduction systems for cleaning and disinfecting disposable respirators, which were being reused by health care personnel.  See the FDA’s new recommendation here and its April 9 letter here.

National Institutes of Health

COVID-19

  • The NIH announced that a new study has found that COVID-19 does not appear to pose a threat to the safety of the nation’s blood supply.  The analysis supports current donor screening guidelines, that do not require testing blood samples for COVID-19 but do require that donors be screened for physical symptoms of COVID-19 and for infections that occurred within 14 days of the blood donation.  The blood of donors with recent COVID-19 infections, or who develop infections after recent donations, cannot be used.  Learn more from this NIH news release.
  • The NIH has started a clinical trial in which adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of different COVID-19 vaccines to determine the safety and effectiveness of individuals receiving vaccines and boosters made by different pharmaceutical companies.  Learn more here.
  • The NIH announced that the experimental drug TEMPOL may be a promising oral antiviral treatment for COVID-19, as indicated by a study of cell cultures by NIH researchers.  Learn more from this NIH news release.

Health Policy News

  • The NIH has launched a clinical trial to assess the safety and effectiveness of an investigational influenza vaccine designed to provide long-lasting protection against multiple flu virus strains.  Healthy participants 18 to 50 years old will receive either a licensed seasonal influenza vaccine or the experimental vaccine that has been formulated to protect against multiple strains of influenza for much longer than one flu season.  Learn more here.

Congressional Research Service

  • The CRS has published a brief report on Medicaid’s money follows the person rebalancing demonstration program.  Find it here.

Medicaid and CHIP Payment and Access Commission

  • MACPAC has published an issue brief on Medicaid base and supplemental payments to hospitals that reviews each type of Medicaid hospital payment, with information on payment goals, payment amounts, and the relationship to other types of Medicaid payments.  It also provides examples showing how the use of supplemental payments varies by state and additional information about how state methods for financing Medicaid payments affect net hospital payments.  Find the report here.

Medicare Payment Advisory Commission

  • The GAO has appointed two new members to the MedPAC board:  Stacie B. Dusetzina, PhD, associate professor of health policy and an Ingram associate professor of cancer research at Vanderbilt University Medical Center in Nashville, Tennessee, andThe following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, June 3.  Some of the language used below is taken directly from government documents.

U.S. Equal Employment Opportunity Commission

Stakeholder Events

FEMA

Monday, June 7

FEMA’s National Exercise Division has developed exercise starter kits with sample documents to assist organizations with planning and conducting tabletop exercises aligning with the updated National Exercise Program 2021-2022 Principal’s Strategic Priorities.  FEMA will host webinars for whole community exercise practitioners.  The webinars will introduce the new exercise starter kits, providing stakeholders with an overview of the kits along with how to use them.  Visit the Homeland Security Exercise and Evaluation Program Webinar webpage to register.

FDA

Friday, June 11
Identification of Medicinal Products:  Path to Global Implementation
Monday, June 11 at 1:00 – 2:30 pm ET  Click here to learn more
The FDA will present updates on the identification of medicinal products standards development and implementation with an emphasis on international collaboration, pilot projects on substance, dosage form, and pharmaceutical identification.

Federal Health Policy Update for Thursday, April 22

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, April 22.

Department of Health and Human Services

COVID-19

  • HHS’s Office of the Assistant Secretary for Preparedness and Response has published a new edition of its online publication The Exchange.  The issue focuses on the work of hospital allied and supportive care providers during COVID-19 and is divided into three subjects:  COVID-19 and acute hospital care, home care, and hospice; the role of allied health care professionals; and engineering and environmental support during COVID-19.  For each subject the issue directs readers to links detailing experiences from the field and to additional resources.  Learn more from the latest edition of The Exchange.
  • HHS has rescinded in its entirety the rule entitled “National Vaccine Injury Compensation Program:  Revisions to the Vaccine Injury Table,” which was finalized during the final days of the previous administration.  The rule made it more difficult for people to seek compensation from shoulder and fainting injuries associated with receiving vaccines.  The published notice repealing it noted that such a change could detract from the COVID-19 vaccination effort.  Learn more from the official Federal Register notice of the rescission.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has published the latest edition of MLN Connects, its weekly online publication about Medicare and Medicare reimbursement matters.  The following is the table of contents of this week’s edition, with links to each item.

News

Compliance

Events

Publications

Multimedia

  • CMS’s Office of Minority Health will hold a two-day virtual forum titled “The Road to Equity:  Examining Structural Racism in Health Care” on April 27 and April 28 to highlight its renewed focus on health equity, addressing structural racism in health care, and establishing federal agencies’ roles as equity partners.  Speakers from various federal and partner agencies will focus on the impact of COVID-19 on health disparities and initiatives to promote equity. Go here for information about the programs’ times, agendas, and registration.
  • CMS has issued a new release of its “Market Saturation and Utilization Data Tool.”  CMS describes the tool as something it uses

…to monitor market saturation as a means to help prevent potential fraud, waste, and abuse (FWA).  Market saturation, in the present context, refers to the density of providers of a particular service within a defined geographic area relative to the number of beneficiaries receiving that service in the area.  The data can be used to reveal the degree to which use of a service is related to the number of providers servicing a geographic region.  There are also a number of secondary research uses for these data, but one objective of making these data public is to assist health care providers in making informed decisions about their service locations and the beneficiary population they serve.

Learn about what is new in this latest release and find links to the data tool in this CMS fact sheet.

The White House

COVID-19

Centers for Disease Control and Prevention

COVID-19

National Institutes of Health

  • The NIH announced that a Phase 2/3 trial to evaluate a new fully-human polyclonal antibody therapeutic targeted to COVID-19 has begun enrolling non-hospitalized people with mild or moderate cases of COVID-19.  Learn more from the NIH news release.

Medicare Payment Advisory Commission

  • MedPAC has posted its formal comment letter on CMS’s final rule on Medicare coverage of innovative technology and its definition of “reasonable and necessary.”  Find the MedPAC letter here.

 

MedPAC Meets

The Medicare Payment Advisory Commission met in Washington, D.C. last week to discuss various Medicare payment issues.

Among the issues discussed at MedPAC’s April meeting were:

  • Medicare skilled nursing facility value-based purchased program.
  • Medicare alternative payment models (APMs).
  • Medicare Advantage benchmark policy.
  • Medicare indirect medical education (Medicare IME) payments.
  • Medicare vaccine coverage and payments.
  • Medicare payment for prescription drugs prescribed on an outpatient basis.
  • Private equity and Medicare.
  • Medicare clinical laboratory fee schedule.

MedPAC is an independent congressional agency that advises Congress on issues involving Medicare.  While its recommendations are not binding on either Congress or the administration, MedPAC is highly influential in governing circles and its recommendations often find their way into legislation, regulations, and new public policy.  Because so many patients of private safety-net hospitals are insured by Medicare, MedPAC’s deliberations are especially important to those hospitals.

Go here for links to the policy briefs and presentations that supported MedPAC’s discussion of these issues.

MedPAC: Go Slow on Expanding Medicare Telehealth

MedPAC wants Medicare to test the impact of telehealth on health care under non-COVID-19 conditions before moving forward with expanding the tool’s use in the Medicare population.

In a news release accompanying its recently released annual report to Congress on Medicare payment policy, the Medicare Payment Advisory Commission writes that

In the report, we present a policy option for expanded coverage for Medicare telehealth policy after the PHE is over. Under the policy option, policymakers should temporarily continue some of the telehealth expansions for a limited duration of time (e.g., one to two years after the PHE) to gather more evidence about the impact of telehealth on beneficiary access to care, quality of care, and program spending to inform any permanent changes. During this limited period, Medicare should temporarily pay for specified telehealth services provided to all beneficiaries regardless of their location, and it should continue to cover certain newly-covered telehealth services and certain audio-only telehealth services if there is potential for clinical benefit.

The policy option also specifies that after the PHE ends, Medicare should return to paying the physician fee schedule’s facility rate for telehealth services and collect data on the cost of providing those services. In addition, providers should not be allowed to reduce or waive beneficiary cost sharing for telehealth services after the PHE. CMS should also implement other safeguards to protect the Medicare program and its beneficiaries from unnecessary spending and potential fraud related to telehealth.

While MedPAC’s recommendations to Congress are not binding on the administration, its work is highly respected and it is considered influential in the development of Medicare reimbursement policy.

Learn more about what MedPAC has to say about telehealth services and other aspects of Medicare payment policy in this MedPAC news release and the MedPAC’s newly released Report to the Congress:  Medicare Payment Policy.

 

MedPAC Meets

The Medicare Payment Advisory Commission met in Washington, D.C. last week to discuss various Medicare payment issues.

Among the issues discussed at MedPAC’s March meeting were:

  • Medicare beneficiary access to care in rural areas
  • skilled nursing facility value-based purchasing program and proposed replacement
  • streamlining CMS’s portfolio of alternative payment models
  • balancing efficiency with equity in Medicare Advantage benchmark policy
  • relationship between clinician services and other Medicare services
  • revising Medicare’s indirect medical education payments to better reflect teaching hospitals’ costs
  • Medicare’s vaccine coverage and payment
  • separately payable drugs in the hospital outpatient prospective payment system

MedPAC is an independent congressional agency that advises Congress on issues involving Medicare.  While its recommendations are not binding on either Congress or the administration, MedPAC is highly influential in governing circles and its recommendations often find their way into legislation, regulations, and new public policy.  Because so many patients of private safety-net hospitals are insured by Medicare, MedPAC’s deliberations are especially important to those hospitals.

Go here for links to the policy briefs and presentations that supported MedPAC’s discussion of these issues.

MedPAC Meets

The Medicare Payment Advisory Commission met in Washington, D.C. recently to discuss various Medicare payment issues.

Among the issues discussed at MedPAC’s January meeting were:

  • hospital inpatient and outpatient payments
  • physician and health professionals payments
  • the possible expansion of the post-acute transfer policy to hospice
  • ambulatory surgical center, outpatient dialysis, and hospice payments
  • Medicare payments for skilled nursing facilities, long-term hospitals, inpatient rehabilitation facilities, and home health services
  • the Center for Medicare and Medicaid Innovation’s development and implementation of alternative payment models
  • the future of telehealth after the COVID-19 public health emergency ends
  • a status report on the Medicare Part D prescription drug program
  • a report on the skilled nursing facility value-based purchasing program and a proposed replacement for that program
  • Medicare’s vaccine coverage and payment policies

MedPAC is an independent congressional agency that advises Congress on issues involving Medicare.  While its recommendations are not binding on either Congress or the administration, MedPAC is highly influential in governing circles and its recommendations often find their way into legislation, regulations, and new public policy.  Because so many patients of private safety-net hospitals are insured by Medicare, MedPAC’s deliberations are especially important to those hospitals.

Go here for links to the policy briefs and presentations that supported MedPAC’s discussion of these issues and go here for a transcript of the two days of meetings.